Senior Manager, eCOA Management F

Bristol-Myers Squibb

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Job Title:
Senior Manager, eCOA (Electronic Clinical Outcome Assessment) Management

Division:
Research and Development (R&D), Global Development Operations (GDO), Global Data Management and Centralized Monitoring (GDM)

Functional Area:
GDM is responsible for clinical trial data acquisition, data management and review, and medical coding for trials across the BMS R&D portfolio.

Position Summary:
The Senior Manager, eCOA Management plays a crucial role in operationalizing eCOA capabilities at the study level for BMS clinical trials. This position directly contributes to advancing the BMS R&D pipeline.

Reporting to:
Associate Director, eCOA Management within GDM

Location:
Full-time, office-based position with flexibility to work from home up to 50% of the time.

Position Responsibilities:

• Lead the operationalization of eCOA instruments for clinical trials, managing the end-to-end process, and providing expertise to clinical study teams.
• Collaborate with eCOA vendors to ensure effective planning, development, and execution of eCOA deployments, meeting study requirements and timelines.
• Ensure timely execution of contracts, licenses, and translations necessary for eCOA delivery.
• Review and coordinate eCOA-related documents with study teams.
• Oversee eCOA development and testing, ensuring requirements are well-defined and met.
• Manage eCOA-related issues during study conduct, collaborating with teams and vendors to resolve them efficiently.
• Ensure quality oversight and management of external partners performing eCOA activities for BMS.
• Manage work assignments to ensure timely delivery.
• Identify and resolve issues impacting eCOA operationalization, escalating as needed.
• Adhere to procedural documents, participating in reviews and updates to ensure they reflect industry standards and regulatory requirements.
• Train and mentor newer team members on key activities and processes.
• Participate in and/or lead continuous improvement initiatives.
• Support preparations and follow-up actions related to Health Authority inspections and internal audits.
• Build strong, productive working relationships with stakeholders across GDM, GDO, and BMS, and effectively communicate with senior management.
• Represent BMS in interactions with external partners and industry groups related to database development.

Degree Requirements:
Bachelor’s degree required

Experience Requirements:

• Minimum of 5 years of relevant industry and clinical trial experience.
• Specific experience with eCOA technologies and instruments, including end-to-end operationalization of eCOA.

Key Competency Requirements:

• Solid understanding of the drug development process with proven expertise in clinical trial start-up, execution, and global eCOA operationalization.
• Strong technical expertise in eCOA processes, instruments, and clinical data acquisition/integration.
• Familiarity with industry-leading tools and emerging technologies supporting eCOA.
• Strong knowledge of GCP/ICH guidelines.
• Proven experience in reviewing technical documents, writing documents, and applying SDLC and system validation principles.
• Demonstrated ability to collaborate effectively across various forums and with external partners.
• Sufficient technical expertise to interface credibly with global development and business partners (medical, development, commercial, regulatory & quality).
• Demonstrated ability to take initiative, be solution-oriented, collaborate with stakeholders, drive activities to completion, and be accountable for results.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients’ lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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